RARE Daily

FDA Grants Fast Track Designation to Reneo’s PMM Therapy

March 24, 2021

Rare Daily Staff

The U.S. Food and Drug Administration granted Fast Track designation to Reneo Pharmaceuticals’ REN001, its experimental therapy for the treatment of patients with primary mitochondrial myopathies.

REN001 is an oral selective peroxisome proliferator-activated receptor delta agonist currently in clinical development for three rare genetic mitochondrial diseases that typically present with myopathy and have high unmet medical needs: primary mitochondrial myopathies (PMM), long-chain fatty acid oxidation disorders (LC-FAOD), and glycogen storage disorder type V (McArdle disease).

The Fast Track process is designed to facilitate and expedite the development of investigational treatments that demonstrate a potential to address unmet medical needs in serious or life-threatening conditions. Programs with Fast Track designation can benefit from early and frequent communication with the FDA in addition to a rolling submission of the marketing application.

“The FDA’s decision to grant Fast Track designation to REN001 signifies an important milestone in our development program,” said Gregory Flesher, president and CEO of Reneo. “There are currently no medications approved to treat patients with PMM, and this designation underscores the importance of developing treatment options for patients who suffer from this debilitating disease.”

Photo: Gregory Flesher, president and CEO of Reneo

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